Barber 2008.

Methods	RCT of TVT vs Monarc TOT
Participants	Setting: 3 USA tertiary academic medical centres Inclusion criteria: 170 women aged over 21 years with USI with or without concurrent POP Exlusion criteria: DO; previous incontinence surgery; PVR > 100 ml; desiring future childbearing; history of hidradenitis suppurativa, inguinal lymphadenopathy, or an inguinal or vulvar mass; history of a bleeding diathesis or ongoing anticoagulation therapy; current genitourinary fistula or urethral diverticulum Mean age in years (SD): Group A: 52 (11); Group B: 53 (12) Mean BMI kg/m² (SD): Group A: 30 (7); Group B: 29 (6) Postmenopausal: Group A: 53/88; Group B: 58/82 Previous continence surgery: Group A: 5/88; Group B: 10/82 MUI: Group A: 76/88; Group B: 66/82 VLPP: < 60 cm/H2O: Group A: 14/88; Group B: 16/82
Interventions	Group A: TVT (n = 88) Group B: TOT (n = 82)
Outcomes	Primary outcome: presence or absence of 'abnormal bladder function', a composite outcome defined as the presence of any the following: incontinence symptoms ‐ any type (ISI > 0), a positive cough‐stress test, re‐treatment for SUI or postoperative urinary retention assessed 1‐year after surgery Secondary outcomes: assessed by use of SF12, PISQ‐12, bladder diary at 12 and 24 months: subjective cure (self‐reported) objective cure (negative cough stress test) mean operating time bladder perforation major vascular injury tape erosion de novo urgency/UUI voiding dysfunction re‐operation QoL: overall improvement in QoL and sexual function scores at follow‐up assessments compared with preoperative baseline scores. No difference between the groups. Used PFDI‐20, PFIQ‐7, PISQ‐12 sexual dysfunction assessed using PISQ‐12. Scores improved post operatively and at 12 months follow up in both groups, though the relative change in scores post‐operatively was small (1.9%) showing moderate responsiveness to incontinence specific outcome measures. There was no significant difference reported between the two groups.
Notes	Intraoperative cystoscopy performed in both groups Concomitant surgery performed in Group A: 48/88; Group B: 45/82 Loss to follow‐up: Group A: 3/88; Group B: 7/82
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "were randomised using computer generated random allocation"
Allocation concealment (selection bias)	Low risk	Quote: "group assignment were concealed in consecutively numbered sealed opaque envelopes"
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "blinding of surgeon and participants was not possible ..."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "all post op assessments were performed by research nurses who were blinded to treatment given"
Incomplete outcome data (attrition bias) All outcomes	Low risk	All accounted for